Method, system, and device for planning and performing guided and free-handed transperineal prostate biopsies

ABSTRACT

A system for planning and performing a guided and free-handed transperineal prostate biopsy includes a transrectal ultrasound probe, an access needle configured to perforate a perineal access site of a patient, a biopsy gun, and a guide. The guide includes a sliding platform, stabilization bars, upper and lower mounts, and fasteners. The system and guide apparatus is used for locating a target area using the ultrasound probe, positioning the ultrasound and the access needle at respective designated points, precisely measuring the distance to a designated point, and obtaining specimens from a precise point in the prostate, wherein the method is performed free-handed, and multiple tissue or cell specimens may be obtained from the prostate through an initial access needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 14/677,286 filed Apr. 2, 2015, which application claims the benefitof U.S. Provisional Patent Application No. 61/974,826, titled “METHOD,SYSTEM, AND DEVICE FOR PLANNING AND PERFORMING GUIDED AND FREE-HANDEDTRANSPERINEAL PROSTATE BIOPSIES”, filed Apr. 3, 2014. The entiredisclosure of each application referenced above is hereby incorporatedby reference herein.

FIELD

The disclosure relates to biopsy procedures and systems. In particular,the disclosure relates to methods, systems, and apparatus useful forplanning and performing guided and free-handed transperineal prostatebiopsies.

BACKGROUND

A biopsy is a medical procedure that involves sampling and removingtissues or cells from a living body for further examination andanalysis. A prostate biopsy may be performed by a care provider fordiagnosis and treatment of a patient's prostate. For example, the vastmajority of patients with an abnormal prostate specific antigen (PSA) orsuspicious results from a digital rectal examination (DRE) undergobiopsy. Typical biopsy procedures include transrectal ultrasound-guided(TRUS) biopsies and transperineal ultrasound-guided (TPUS) biopsies.

TRUS involves obtaining tissue or cell specimens by passing a biopsyneedle or other biopsy instruments through the rectal wall and into theprostate at various locations using a sagittal imaging plane. The biopsyneedle or other biopsy instruments may be guided by ultrasound in asagittal plane. There are disadvantages associated with TRUS. Inparticular, the patient may be required to take antibiotics prior to theprocedure to reduce the risk of infections. Also, TRUS requires thepatient to perform bowel preparation, which is a procedure usuallyundertaken before the biopsy, for cleansing the intestines of fecalmatter and secretions. Further, the passage of the biopsy needle throughthe rectal wall may introduce bacteria from the rectum into theprostate, such as coliform bacteria that may lead to an infection orother complications. Additionally, many clinically significant prostatecancers are found in locations of the prostate that are often toodifficult to access when using the transrectal approach.

TPUS includes obtaining tissue or cells specimens by passing one or morebiopsy needles through the perineum and into the prostate. TRUS has beenfavored over TPUS. Unlike TRUS, TPUS does not require a patient to takeantibiotics prior to the procedure or to undergo the bowel preparationfor lowering the risk of bacterial issues. Further, TPUS uses a moreeffective route to access the prostate and is capable of accessingtarget locations that may be difficult to access utilizing thetransrectal approach in comparison with TRUS. In addition, the needledoes not pass through the rectal wall which eliminates the riskassociated with TRUS of coliform bacteria entering the prostate or thebloodstream.

Systems configured for TPUS include a biopsy grid that may be fixed to,for example, a floor, platform, or table on which the patient receivingthe biopsy lies. The biopsy grid may provide multiple apertures throughwhich a biopsy needle or other biopsy instruments may be inserted. Anultrasound probe is fixed directly to the apparatus and is used toaxially guide the biopsy needle or other instruments, for example otherbiopsy instruments. Thus, TPUS systems require imaging in an axial planeof the ultrasound or a transverse transducer for positioning the biopsyneedle.

SOME EXAMPLE EMBODIMENTS

Related art systems and prostate biopsy TPUS methods do not allowfree-hand movement of the ultrasound probe, and heavily rely on theaxial ultrasound plane to confirm positioning of the biopsy needle orother instruments. Moreover, such systems and methods include extractingprostate tissue specimens by delivering separate punctures into thetransperineal tissue. Also, a care provider executing TPUS procedureusing related art systems may experience substantial difficulty infreely handling and positioning a biopsy needle at a desired targetlocation of the prostate relying on the sagittal plane in using the TRUSmethods.

An apparatus in accordance with an embodiment may include an upper mountand a lower mount. The lower mount may be configured to connect with theupper mount to secure a transrectal probe therebetween. The upper mountmay be configured to support an access needle, the access needleconfigured for perforation of subcutaneous tissue of a perineum at anaccess site of a target area of a patient. The upper mount may beconfigured to guide the access needle whereby movement of the accessneedle is fixed relative to movement of the transrectal probe.

A system in accordance with an embodiment may include a biopsy guide anda transrectal transducer fixed to the biopsy guide. The biopsy guide maybe configured to guide an access needle to perforate an access site insubcutaneous tissue of a perineum, whereby movement of the access needleis fixed relative to a movement of the transrectal transducer.

A method of performing a prostate biopsy in accordance with anembodiment may include imaging a prostate in an axial plane and asagittal plane with a transducer providing a real-time image, locating atarget area of the prostate, and positioning an access needle and anaccess site in subcutaneous tissue of a perineum wherein the access siteis at a midpoint between a lateral edge of the prostate and a urethraalong a first axis and a midpoint between an anterior capsule and aposterior capsule along a second axis. The method may include guiding abiopsy instrument along a sagittal plane to the target using thereal-time image, and obtaining one or more specimens of the prostatethrough the access needle with a biopsy instrument.

Accordingly, there is a demand for transperineal biopsy methods,systems, and apparatus that enables a biopsy that is less burdensome forthe patient and for the practitioner performing the biopsy, increasedguidance of needle or other biopsy instruments, and with a higher rateof efficacy and lower rate of health risk than related art TPUS and TRUSsystems and methods. Apparatus, systems, and methods disclosed hereinsatisfy these demands.

BRIEF DESCRIPTION OF THE DRAWINGS

Various exemplary embodiments are illustrated by way of example, and notby way of limitation, in the figures of the accompanying drawings inwhich like reference numerals refer to similar elements and in which:

FIG. 1 shows a side view of a guide secured to a probe in accordancewith an embodiment;

FIG. 2A shows an internal view of a guide fastener in accordance with anembodiment;

FIG. 2B shows a sheath-based guide fastener in accordance with anembodiment;

FIG. 2C shows a zip-tie-based guide fastener in accordance with anembodiment;

FIG. 3 shows a top view of a guide secured to a probe in accordance withan embodiment;

FIG. 4 shows a cross-sectional view of the back of a guide secured to aprobe in accordance with an embodiment.

FIG. 5 shows a magnified view of a guide secured to a probe inaccordance with an embodiment;

FIG. 6 is a magnified top view of a guide fastener in accordance with anembodiment;

FIG. 7 is a magnified view of a guide in accordance with an embodiment;

FIG. 8 is a side view of a biopsy instrument that has penetrated theprostate in accordance with an embodiment;

FIG. 9 is a front view of a designated area of the prostate where abiopsy instrument will penetrate in accordance with an embodiment;

FIG. 10 is a side view of a biopsy instrument penetrating the prostatein accordance with an embodiment;

FIG. 11 is a front view of a designated area of the prostate where abiopsy instrument will penetrate with areas in which the cell or tissuespecimen has already been extracted in accordance with an embodiment;

FIG. 12 is a top view of a biopsy instrument that has penetrated theprostate in accordance with an embodiment;

FIG. 13 is a side view of a prostate and the path of the biopsyinstrument;

FIG. 14 is a front view of a guide positioned at a designated area ofthe prostate in accordance with an embodiment;

FIG. 15 is a side view of a guide positioned at a designated area of theprostate in accordance with an embodiment;

FIG. 16 is a front view of a guide positioned at another designated areaof the prostate in accordance with an embodiment;

FIG. 17 is a side view of a guide positioned at another designated areaof the prostate;

FIG. 18 is a front view of a guide positioned at a higher designatedarea of the prostate, according to one embodiment;

FIG. 19 is a right side view of a guide positioned at a higherdesignated area of the prostate in comparison with that shown in FIGS.14-17 in accordance with an embodiment;

FIG. 20 is a side view of a guide and a biopsy instrument firmlypenetrating a fat plane and perineum skin of a patient in accordancewith an embodiment;

FIG. 21 is a view of an access needle positioned at the access site inaccordance with an embodiment;

FIG. 22 is a magnified view of the right side of a prostate and a biopsyinstrument in accordance with an embodiment;

FIG. 23 is an image of the front side of a prostate and a biopsyinstrument being retrieved from the prostate, and other targeted areasin accordance with an embodiment;

FIG. 24 shows a method for performing a prostate biopsy in accordancewith an embodiment;

FIG. 25 is an ultrasound image showing a transducer, access needle pathextending from an access point at a perineal site to a prostate, and aprostate; and

FIGS. 26A-26C show side views of a guide configured with a pivotingmount in accordance with an embodiment.

DESCRIPTION OF SOME EMBODIMENTS

The apparatus, systems, and methods provided herein enable real-timevisualization, free-handed, guided, and multi-sample transperinealmethods for performing a biopsy. The methods, systems, and apparatusprovided herein also enable a complete biopsy of the prostate with onlyone perforation, or with minimal perforations of a patient's skin by wayof an initial access site, such that the access needle is freelymoveable. The biopsy guide may be placed on or fitted to an assortmentof ultrasound probes of different sizes and shapes due to an adjustablemounting system. The guide may be configured to fit to the probe usingany suitably configured fastening system. For example, the guide may beconfigured as a sleeve that is formed to slide over an end of a probeand into an operable position. Alternatively, the guide may beconfigured to fit to a probe using screws, flanges, zip ties, or othertemporary, permanent, or semi-permanent fastening systems.

In one embodiment, the guide allows biopsies of one or more tissue orcell samples to be obtained through an initial access needle, whileproviding direct, real-time ultrasound visualization by, for instance,fixing a position of the access needle relative to an ultrasound probeto provide. For example, the guide is fixed to an ultrasound probe thatis not fixed and may be freely moveable in operation. Stabilization barsthat are built into the guide facilitate the positioning and holding ofthe perineal skin and subcutaneous tissue to allow positioning of theaccess needle. The position of the access needle is facilitated bylocking the access needle into the subcutaneous tissue of the perineumusing a sliding platform that allows a user, such as a medicalpractitioner or patient caregiver, to place the access needle along asagittal transducer plane at optimal positions for obtaining prostatebiopsies. In some embodiments, upon placement of the access needle intoa locked position, for example, in the pelvic floor, a user may thenpass a biopsy needle through the access needle to a desired location ofthe prostate. In yet further embodiments, the passing of the biopsyneedle through the access needle and to the prostate may be facilitatedby direct sagittal plane visualization based on the alignment of theaccess needle.

Methods and systems provided herein do not require a patient to takeantibiotics at any point prior to the biopsy procedure, nor do theyrequire a patient to undergo bowel preparation in advance of theprocedure. Methods, systems, and apparatus can reduce or eliminatemultiple skin perforations by using a single access location or accesssite, while allowing multiple extractions of tissue or cell specimensfrom the prostate. Methods, systems, and apparatus in accordance withembodiments allow for real-time visualization during a free-handed,guided, transperineal approach, while also facilitating a completeassessment of the prostate with, for example, only one perforation ofthe patient's skin wherein the access needle is freely moveable in eachplane.

Methods, systems, and apparatus of embodiments may include andfacilitate treatment that uses a cryoablation probe for focal therapy ofprostate cancer, a radiofrequency instrument, a thermotherapyinstrument, any instrument for treatment of the cancerous area, or acombination of any of these instruments.

Methods, systems, and apparatus of embodiments enable planning andperforming the free-hand transperineal prostate biopsies under theguidance of a device and of a real-time transducer in the sagittalimaging plane.

The biopsy is performed using a system that includes a biopsy guide, atransducer, an access needle, and a biopsy instrument. The access needlemay allow the anesthesia to be injected into the patient, and the tissueor cell specimens of the prostate to be extracted. If anesthesia isused, a syringe may be included in the system. The transducer may be anultrasound probe or any other type of device that is capable of causinga visualization of the prostate in a display device. In embodiments, thebiopsy guide may be disposable. In embodiments, the biopsy guide may beformed of materials intended for a single use. In other embodiments, thebiopsy guide is reusable. In some embodiments, the biopsy guide may beformed of materials intended for multiple uses.

The guide may include a sliding platform, stabilization bars, one ormore upper and lower mounts, and a fastener. The upper and lower mountsmay be curvilinear in shape. The upper and lower mounts may bepositioned proximally or distally along an ultrasound probe, such as atransrectal ultrasound probe. The configuration and positioning of theupper and lower mounts are adjustable based on the shape of theultrasound probe and the patient's body habitus.

The guide may be made of any material such as a plastic or metallicmaterial. The guide may be disposable and made of a biodegradableplastic material. In other embodiments, the guide may be reusable andmade of stainless steel. The dimensions, for example, the length, width,height, depth, and breadth of the sliding platform, stabilization bars,upper and lower mounts, and the fastener may vary and may be adjustable.The variable and adjustable dimensions, for example, of thestabilization bars, provide a user with flexibility in achieving andmaintaining the guide in an appropriate ultrasound plane whileperforming biopsy procedures, while the user's patients may vary in sizeand levels of perineal subcutaneous tissue and fat. In a patient with anexcessive amount of perineal subcutaneous tissue and fat, a largerstabilization bar will assist in locking the guide in the properultrasound plane.

The adjustable stabilization bars and mounts may be curvilinear inshape, allowing the guide to be placed proximally or distally along anycylindrical instrument, such as the transrectal ultrasound probe, whichis determined by the surgeon based on the shape of the probe and thepatient's body habitus. This allows the guide to be mounted to anyassortment of ultrasound probes. Similarly, the platform may, forexample, have various thicknesses.

The stabilization bars may be fixed to a top portion of the uppercurvilinear mounts of the guide, and may extend beyond the front edge ofthe upper mounts. The stabilization bars may extend beyond the frontedge of the upper curvilinear mount by approximately 8 mm. The guide maybe approximately 60 mm wide, or the guide may be approximately 50 mmlong, for example. The stabilization bars may have grooves foraccommodating a sliding platform that is shorter in length than thestabilization bars. The grooves being configured to allow the platformto slide forward and backward along the stabilization bars.

An inner portion of the stabilization bars may have built-in grooves.The grooves accommodate a sliding platform which is shorter in lengththan the stabilization bars. This allows the sliding platform to slidefrom the back to the front of the stabilization bars. The stabilizationbars may include a resistance as to prevent the sliding bar to freelymove back and forth on the stabilization bar. This resistance may beintroduced by the sliding platform or both the stabilization bar and thesliding platform. The resistance may be provided by a strip of rubber orany other material capable of providing friction or other. The strip maybe curvilinear. The resistance may be generated by a mechanical system,such as a spring mechanism.

The sliding platform may have a hole through the platform. In someembodiments, the hole is drilled in the center of the platform. The holecan accommodate various types of needles, including access needleshaving various diameters, for example, spinal needles having a gauge inthe range of 14-18. The hole can also accommodate needles having variouslengths. The lengths of the needle may depend, in part, on the bodyhabitus. The needle may be a reusable needle, such as a reusable spinalneedle. The needle may be a disposable needle, such as a disposablespinal needle.

A flange of the guide secures the placement of the access needle to theguide. The flange may be configured to snap into the guide to secure theneedle. The flange may be secured to the guide by other securingmechanisms. The flange can be of various shapes and configurations. Forexample, the flange may be u-shaped. As another example, the flange mayhave a thin or slim configuration. The guide assists in providing theappropriate angle of penetration and direction of the access needle, orother instruments that may be used in combination with the guide.

The hole in the guide is placed so that once the guide is mounted to theultrasound probe, the drilled hole will be parallel to the sagittaltransducer. The drilled hole may also accommodate the tip of a biopsygun, or any other biopsy instrument. The sliding platform may beinterchangeable and may be removed to allow placement of another slidingplatform with a different sized to permit different sizes of needles andother instruments. The hole may be configured to accommodate acryoablation instrument, a radiofrequency instrument, thermotherapyinstrument, or any other instrument for diagnosis and treatment of abodily tissue, including a cancerous area of a prostate.

The platform may have or define a predrilled hole in the center of theplatform that can accommodate various sizes of needles and instruments.For example, the hole may be configured to accommodate a needle having arange of 14-18 gauges, such as a reusable 14 gauge spinal needle.Central hole placement on the platform provides enables alignment of thehole with a sagittal transducer when the guide is mounted to anultrasound probe. The platform may have multiple holes to accommodatevarious applications and body habitus. Further, the platform may be ofvarious thicknesses.

Once the one or more upper curvilinear mounts are placed at the desiredlocation on the transrectal ultrasound probe, the access hole for aneedle, such as a 14 gauge reusable spinal needle, will remain a fixeddistance from the ultrasound probe. In embodiments, having one or morelower curvilinear mounts, the mounts may be positioned to cradle anupper aspect of the ultrasound probe.

At least two lower mounts are provided and may be individuallypositioned to accommodate various types of probes, which may havevariable diameters along their shafts. In embodiments, a probe, such asa transrectal ultrasound probe, may have one or more diameters along theprobe's shaft. In yet further embodiments, one end of the guide may befixed at a location of the probe having a different diameter than thelocation where the other end of the guide is fixed. The separate lowermounts allow for the fixation of the guide, even with varying probediameters.

The lower mount of the guide may include a lower right mount and a lowerleft mount connected by an adjustable mid joint or fastener. Theadjustable mid joint or fastener allows the guide to be secured to theprobe even if the diameter of the shaft of the probe is longer than thewidth of the lower mount. The mid joint or fastener may be flexible toallow the right lower mount to form an acute angle with the left lowermount. This also allows for fixation of the guide to a probe shaft thatis not circular in shape.

The lateral edges on both ends of the lower mounts may contain a notchedpost. Corresponding locations of the upper mounts contain holes, such assquare shaped holes, to accommodate the notched post of a correspondinglower mount. An upper aspect of each hole includes a flange for lockingthe notched post in a fixed position. This configuration allows thelower mounts and the upper mounts to be secured to each other and to theprobe.

Methods may include locating a suspicious area, positioning an accessneedle, and obtaining one or more tissue or cell specimens from anaccurate point in the prostate. The method allows for multiple tissue orcell specimens to be obtained from a bodily organ, such as the prostate,and permits access to the prostate from different angles through asingle initial access needle. The method may include calculating thevolume of the prostate by positioning the access needle at a mid pointin the x axis from the lateral edge of the prostate to the urethra.

Methods may be performed using no anesthesia. Alternatively, ananesthetic may be used. For example, the anesthetic may be lidocaine, orany type of local anesthetic. The lidocaine may include 1 or 2% of alidocaine solution.

The suspicious area or bodily organ may be located by using atransducer. The transducer may be any type of probe for accessing andviewing a targeted site or object, such as an ultrasound probe, or anytype of transducer capable of providing visualization of the prostateand/or instruments and devices for diagnosis and treatment of thetissue. The biopsy may be performed using a biopsy gun, a suctiondevice, or any type of instrument that is small enough to be introducedthrough the access needle and capable of extracting the tissue or cellspecimen. The biopsy may be performed while the patient is in a dorsallobothy position, prone position, or any position that allows for accessto the perineal area.

Methods may include applying an antiseptic solution to the perinealarea. The antiseptic solution may include betadine, or any othersubstance that reduces the possibility of infection, sepsis, orputrefaction. Methods may include applying bacitracin to the skin at thepuncture site or any other type of topical preparation for preventingthe possibility of infection.

Methods may include attaching a needle to a luer lock syringe, which maycontain an anesthetic, or any other type of device capable of retainingits contents and dispensing its contents through the needle. A biopsygun or any other instrument that may be attached to the needle and usedfor inserting or extracting any substance thru the lumen of the accessneedle.

Methods may include releasing the syringe from the needle after theanesthetic is injected. Methods may include dividing the prostate inthree different regions and designating lateral, mid, apical prostate,and may include labeling the tissue or cell specimen containers, whichwill identify the tissue or cell specimens.

Methods may include securing the guide to the probe. This will permitthe practitioner to take the biopsy gun as many times as necessary usinghis/her other hand, and, consequently, extract multiple tissue or cellspecimens. It is contemplated that this can be done without assistanceof any other person, and that the biopsy gun may also be attached to theguide in order to permit the surgeon to, for example, label thecontainer with the tissue or cell specimen while performing the biopsy.Methods may also include monitoring all the actions in the prostate byway of a display device that provides images captured by the probe.

Methods may include moving the needle in x, y, and z planes. By beingable to move the needle in x, y, and z planes, the surgeon is capable ofextracting tissue or cell specimens from several different areas of theprostate without having to retrieve the needle and preventing otherperforation of the patient's skin. In embodiments, movement of theneedle within the patient's body is facilitated by using a displaydevice.

Methods may include removing the access needle from the perineal area.This may be done while the biopsy gun is secured to the access needle orafter the biopsy gun has been detached from the access needle.

Methods may include realigning the needle in the desired prostateregion. If the surgeon wishes to start at the right lateral prostateregion and notices that the needle tip is not directed at the lateralregion, the surgeon rolls the ultrasound probe slightly and to note thatthe needle tip is directed to the desired region, then the surgeon mayrealign the needle to obtain tissue or cell specimen. The surgeon mayrealign the needle using one hand while having the needle attached tothe biopsy gun, which may be attached to the probe through the guide.

Methods may include identifying the areas in which biopsy have alreadybeen performed. After each extraction of tissue or cell specimen duringthe biopsy, a hyperechoic streak remains visible on ultrasound display.This allows the surgeon to identify the area of the prostate and that anextraction has been made, as to allow the surgeon to prevent overlap ofextractions.

In another embodiment, the method includes identifying the path of theurethra. This allows the surgeon from preventing passing the biopsyneedle thru or into this path.

FIG. 1 is a side view of a guide 100 secured to a probe including astabilization bar 101, fasteners 102, probe 103, lower mounts 104, andan upper mount 105. The stabilization bar 101 is an extension of theupper mount 105, as further discussed in FIG. 4. In embodiments, thedistance between the fasteners 102 and the upper mount 105 may beadjustable to accommodate various applications and body habitus.

FIG. 2A is an internal view of a guide's fastener, including an aperture201, teeth 202, and a flange 203. The flange 203 may be an extension ofthe aperture 201, which is part of the upper mount 105. Aperture 201will allow the teeth 202 to be inserted into the upper mount 105, andthe flange 203 will lock the teeth 202, which is connected to lowermount 104, to the upper mount 105. The aperture 201 with flange 203 andteeth 202 allows for adjusting the height of the guide 100.

In one embodiment, the fastener (e.g., via the aperture 201, flange 203,and/or the teeth 202) can be configured to fasten the guide 100 to theprobe 103 with, e.g., varying levels of tension to provide foradjustments of the relative positions of the guide 100 and the probe 103even after the guide 100 has been mounted to the probe 103. For example,the fastener 102 can provide a first level of tension sufficient to holdthe position of an access needle (e.g., introduced through a hole orother needle mount of the guide 100) rotationally fixed to the probe 103while still allowing for a forward or reverse sliding of the probe 103with respect to the guide 100. By way of example, the forward or reversesliding adjustment can be performed to adjust the penetration depth ofthe probe 103 with respect to the patient depending on a size of thepatient. Once the final adjustment is made, the fastener can be actuatedto final position or tension that will then lock further adjustments ofthe positioning of the guide 101 relative to the probe 103.

It is noted that the guide's fastener as described above is one exampleembodiment among other possible example fasteners that are applicable tovarious embodiments of the guide 100. Accordingly, it is contemplatedthat various embodiments of the guide 100 may use any now known or laterdeveloped fastening system that can secure the guide 100 to the probe103.

By way illustration and not limitation, examples of two fasteners arediscussed with respect to FIGS. 2B and 2C. FIG. 2B shows a sheath-basedfastener whereby the fasteners 102 are attached to a sheath 211 that isconfigured to slide over an end of a probe 103 and into an operableposition. Although the sheath 211 is shown as a closed sheath, inanother embodiment, the sheath 211 can be configured as a sleeve thatthis open-ended to slide over the probe 103. By way of example, thesheath 211 can be made of a flexible material (e.g., rubber) to providefor stretching and tension on probe 103.

In another embodiment, as shown in FIG. 2C, the guide 100 can beconfigured with a zip-tie style fastener in place of a lower mountmechanism to secure the guide 100 to the probe 100. In other embodiments(now shown), the guide 100 may be configured to fit to the probe 100using screws, flanges, or other temporary, permanent, or semi-permanentfastening systems. In addition, although the fasteners 102 of the guide100 may be configured as generic and adjustable fasteners that cansupport probes of a variety sizes and shapes, it is also contemplatedthat the fasteners can be fit to specific models of probes forcustomized applications.

FIG. 3 is a top view of a guide secured to a probe. This figure includesa sliding platform 301, a drilled hole 302, stabilization bars 101,fasteners 102, an upper mount 105, and a probe 103. As previouslydescribed, in one embodiment, the drilled hole 102 can accommodate orsupport various sizes and/or configurations of needles (e.g., straightneedles, curved needles, etc.) and instruments for performing a biopsyso that the needle can be aligned relative to the probe 103, thereby,also providing an alignment between the needle and an image produced bythe ultrasound probe 103. In one embodiment, the drilled hole 102 cansupport an access needle through which a biopsy needle or otherinstrument can be introduced at a known alignment with respect to theprobe 103. In addition, although the hole 102 to support, e.g., anaccess needle or other instrument is showed in a central midlineposition, the location of the hole can be configured at any position ofthe guide 100.

FIG. 4 is a cross-section view of the back of a guide secured to a probeincluding a sliding platform 301, drilled hole 302, stabilization bars101, lower mount 104, upper mount 105, fasteners 102, and probe 103.

FIG. 5 is a magnified view of FIG. 1. FIG. 5 demonstrates minimumdimensions of preferred embodiments, which includes stabilization bars101 and upper mount 105 from 30 mm to 50 mm long; the upper mount 105with a height ranging from 10 mm to 15 mm; the stabilization bars 101with a height that is about ⅓ of the height of the upper mount 105;fasteners 102 with a height of about 25 mm and 10 mm wide; a lower mount104 10 mm wide. Additionally, the off-set 501 from the distal point ofthe stabilization bar 105 to the fasteners 102 may be 5 mm. It iscontemplated that any of these dimensions may vary, including thestabilization bar 101, which may be longer than the upper mount 105.

FIG. 6 is a magnified internal view of the guide fastener shown in FIG.2. FIG. 6 demonstrates minimum dimensions of preferred embodiments. Thefasteners 102 may have an aperture 201 to accommodate teeth 202, whereinthe fastener 102 is 5 mm to 10 mm wide. Additionally, the slidingplatform 301, which may be from 12 mm to 25 mm wide, is slightly shorterthan the distance between the two stabilization bars 101 as toaccommodate the sliding platform while also securing it to the guide100.

FIG. 7 is a magnified view of the guide depicted FIG. 3, without theprobe 103. FIG. 7 also demonstrates minimum dimensions of preferredembodiments, wherein the height of the upper mount 105 ranges from 5 mmto 10 mm; and the teeth 202 is from 5 mm to 8 mm wide.

FIG. 8 is a side view of a biopsy instrument that is about to penetratethe prostate, including a prostate 801, a probe 103, a biopsy instrument802, a perineum skin 803, an anus 804, and a perforation point 805. Theprobe 103 is inserted into the anus 804 to provide real-time images ofthe biopsy, including images of the biopsy instrument 802 and theprostate 801. It is contemplated that the biopsy instrument 802 includesa needle and any other instrument capable of performing a biopsy.

FIG. 9 is a front view of a targeted area 902 of the prostate 801. FIG.10 is a side view of a biopsy instrument penetrating the prostate 801,including a targeted area 902 of the prostate 801. The targeted area 902is reached by biopsy instrument 802 after perforating perineum skin 803.

FIG. 11 is a front view of a targeted area of the prostate where abiopsy instrument will penetrate with areas in which the cell or tissuespecimen has already been extracted. FIG. 11 depicts both an extractedarea 1101 and a targeted area 902. The possibility of viewing the areain which the cell or tissue specimen has already been extracted permitsthe practitioner to avoid placing the access needle in an area that cellor tissue specimen has already been extracted. This allows the biopsy tobe more efficient and more accurate.

FIG. 12 is a top view of FIG. 8, depicting a prostate 801, perineum skin803, a probe 103, and a biopsy instrument 802. FIG. 13 is a right sideview of a prostate and the path of the biopsy instrument including thepath of the biopsy instrument 1301 and the perforation point 805. FIG.13 illustrates that only one initial perforation to the skin of thepatient is necessary in order to extract one or more cell or tissuespecimens.

FIG. 14 is a front view of a guide determining a lower targeted orsuspicious area 1401 of the prostate in which to penetrate the biopsyinstrument, a prostate, and a probe. FIG. 16 is a front view of a guidedetermining a mid target or suspicious area 1601 of the prostate inwhich to penetrate the biopsy instrument, a prostate, and a probe. FIG.18 is a front view of a guide determining a higher targeted orsuspicious area 1801 of the prostate in which to penetrate the biopsyinstrument, a prostate, a probe. FIGS. 14, 16, and 18 demonstrates thevariety of angles and positions in which a guide may be positioned inorder to reach several regions of the prostate, such as the lateralregion, mid region, and apical region. In order to the able to reachthese areas, FIGS. 14,16, and 18 demonstrate how the upper mount 105,the stabilization bars 101, or a combination of thereof can adjust inorder to reach a lower targeted or suspicious area 1401, a mid targetedor suspicious area 1601, or a higher targeted or suspicious area 1801 ofthe prostate.

FIGS. 15, 17, and 19 demonstrate a side view of FIGS. 14, 16, and 18 andthe paths of the biopsy instrument 1301 taken by a biopsy instrument toreach lower targeted or suspicious area 1401, a mid targeted orsuspicious area 1601, or a higher targeted or suspicious area 1801 ofthe prostate.

FIG. 20 is a right side view of a guide, and a biopsy instrument firmlypenetrating a fat plane of perineum skin, including offset 501 of astabilization bar 101. This allows for stabilization in a patient withan excessive amount of perineal subcutaneous tissue, fat, or acombination thereof. A larger stabilization bar 101 will assist inlocking the guide in the proper ultrasound plane. Accordingly, theoffset 501 may longer than 5 mm for these purposes.

FIG. 21 is a front view of a prostate, a probe, a targeted or suspiciousarea, wherein the biopsy instrument may reach any area of the prostate.FIG. 21 demonstrates that the biopsy instrument can reach the entireprostate while using only one perforation point 805. After obtaining onecell or tissue specimen, the biopsy instrument 802 may be partiallyretrieved from the perineum area at a point in which the distal point ofthe biopsy instrument 802 is redirected to another targeted orsuspicious area. Then, the biopsy instrument (usually the needle of thebiopsy instrument) is inserted to the second targeted or suspicious areafor obtaining a cell or tissue specimen of another area of the prostate.

FIG. 22 is a magnified view of the right side of a prostate and a biopsyinstrument. FIG. 22 depicts the location of the biopsy instrument insidethe prostate and the other paths in which the biopsy instrument may takeutilize for additional samples or retrieval. In embodiments, the biopsyneedle or other instruments do not reach the initial part of the penis,which is in a different plane from the prostate.

FIG. 23 is an image of the front side of a prostate and a biopsyinstrument being retrieved from the prostate, and other targeted areas.FIG. 23 shows a procedure being applied to the apical region of theprostate.

The urethra should be avoided in any part of the procedure, but it ismostly important when extracting cell or tissue specimens from theapical region of the prostate, when the chances of perforation isgreater. After several extractions, the practitioner is able to see theblood streak from where the cell or tissue specimen was taken so as toavoid overlapping.

After this procedure, the patient may be put with restriction for nomore than 1 day. If the patient is put on restriction for 1 day, afterthe one-day-restriction, no restriction is made.

In an embodiment, the biopsy system performs the processes 2400 of FIG.24. At 2401, a patient is prepared for the biopsy procedure by havingthe patient get into a lithotomic position, prone position, or anyposition that allows for access to the perineal area. The biopsyprocedure may be a prostate biopsy. In some embodiments, the patient'sscrotum is elevated using, for example, two strips of plastic tape. Theperineum is prepared with an antiseptic solution to the perineal area,for example, the antiseptic solution may include betadine.

At 2402, a target area or object, such as the prostate, is imaged.Imaging may be performed with a transducer, such as an ultrasound probe.Imaging of a target area may be in a sagittal and/or axial plane and maybe performed in real-time with direct visualization. Utilizing thereal-time image, a user can identify areas of interest, e.g. suspiciousareas or the target area or object at 2403.

The user may determine an access site for positioning an access needle.At 2404, an access needle is positioned at an access site insubcutaneous tissue of the perineum. The access site may be at amidpoint between a lateral edge of the prostate and the urethra along anx axis, and a midpoint between an anterior capsule and a posteriorcapsule along a y axis. The access needle is guided and positioned atthe access site by using the guide.

At 2405, a biopsy instrument is guided to the target or suspicious areasor object. The biopsy instrument may include a biopsy needle. Theguiding of the biopsy instrument can be facilitated by using thereal-time visualization provided by the transducer. Real-timevisualization also facilitates obtaining tissue or cell specimens froman accurate point in the prostate, for example. The method allows forone or more tissue or cell specimens to be obtained from a bodily organ,such as the prostate at 2406, and permits access to the prostate fromdifferent angles through a single initial access needle.

At 2407, the biopsy instrument may be retrieved and removed from thepatient. The method may include calculating the volume of the prostateby positioning the access needle at a mid point in x axis from thelateral edge of the prostate to the urethra.

FIG. 25 shows an ultrasound 2501 showing a transrectal probe 2503 and anaccess needle guide line 2505. The needle guide line enables thepractitioner to observe a needle path whereby the access needle hascontacted the prostate 2507, thereby enabling the practitioner to avoidoverlapping sampling, and to avoid perforating the prostate.

FIGS. 26A-26C show side views of an alternative embodiment of a guide2600 secured to a probe including a stabilization bar 101, fasteners102, probe 103, lower mount 104, and an upper mount 105. Thestabilization bar 101 is an extension of the upper mount 105, as furtherdiscussed in FIG. 4. In embodiments, the distance between the fasteners102 and the upper mount 105 may be adjustable to accommodate variousapplications and body habitus.

The guide 2600 includes a sliding platform 301. The guide is fitted tothe probe 103 by a sleeve 2607. The sleeve 2607 is formed by the lowermount 104 and the upper mount 105. The sleeve 2607 may be configured toslide over an end of the probe 103 into an operable position as shown inFIGS. 26A-26C. The sleeve 2607 is a partial sleeve that has an openingat both ends of the sleeve 2607 to enable slidable mounting to andremoval from the probe 103.

The sliding platform 301 of the guide 2600 may be pivotably mounted toenable movement in a direction perpendicular to a longitudinal axis ofthe probe 103, as shown in FIGS. 26A-26C. In particular FIGS. 26A-26Cshow that the sliding platform 103 is fixed to the guide at a pivotpoint 2608. The sliding platform 103 is configured to pivot at pivotpoint 2608 to enable, for example, normal or vertical adjustment of anaccess needle (not shown) in directions perpendicular to a longitudinalaxis of the probe 103 while ensuring that a longitudinal axis of theaccess needle (not shown) remains parallel to the longitudinal axis ofthe probe 103.

For example, FIG. 26A shows a sliding platform 301 in a first positionat which a lateral planar surface of the platform 301 extends in adirection parallel to the longitudinal axis of the probe 103. FIG. 26Bshows the sliding platform 301 pivoted to a second position wherein afront end the platform 301 is disposed a distance from the probe 103that is greater than a distance between an opposite rear portion of theplatform 301 and the probe 103. FIG. 26C shows the sliding platform 301pivoted to a third position wherein the rear end of the platform 301 isdisposed a distance from the probe 103 that is greater than a distancebetween the opposite front end of the platform 301 and the probe 103.

In another embodiment, the method may be performed without the patienttaking antibiotics or undergoing bowel preparation before having theprocedure. During the procedure, the practitioner may administer ananesthetic to the patient, for example, lidocaine, or any type of local,anesthetic. The lidocaine may be included in a solution having 1% oflidocaine.

In an embodiment, the suspicious area is located by using a transducer.The transducer may be any type of transrectal robe for prostate cancer,such as an ultrasound probe, or any type of transducer capable ofimaging the prostate and the extraction device. The biopsy may beperformed using a biopsy gun, a suction-mechanism, or any type ofinstrument that is small enough to be introduced through the accessneedle and capable of extracting the tissue or cell specimen. The biopsymay be performed while the patient is in a lithotomy position, proneposition, or any position that allows for access to the perineal area.

In another embodiment, methods may include applying an antisepticsolution to the perineal area such as betadine, or any other substancethat reduces the possibility of infection, sepsis, or putrefaction.

In another embodiment, the ultrasound probe may be a B&K 8848transrectal ultrasound probe, or any other ultrasound capable of causingvisualization of the prostate and the extraction device. The frequencyrange may be 5-12 MHZ, and the focal range may be 3-60 mm. Theultrasound probe may be able to cause the visualization of the prostateand extraction devices at least in the axial plane, sagittal plane, or acombination thereof.

In another embodiment, methods may include attaching a needle to a luerlock syringe, which may contain an anesthetic, or any other type ofdevice capable of retaining its contents and to dispense its contentsthrough the needle. A biopsy gun or any other instrument may be attachedto the needle for inserting or extracting any substance through thelumen of the access needle.

In another embodiment, the method includes releasing the syringe fromthe needle after the anesthetic is injected. The method may includedividing the prostate in three different regions and designatinglateral, mid, apical prostate, and may include labeling the tissue orcell specimen containers, which will identify the tissue or cellspecimens.

In another embodiment, a biopsy gun may be an 18 gauge biopsy gun, orany other size that is capable of being coaxially inserted thru thelumen of the access needle.

In another embodiment, methods may include securing the guide to theprobe. This will permit the practitioner to take the biopsy gun as manytimes as necessary using his or her other hand, and, consequently,extract multiple tissue or cell specimens. It is contemplated that thiscan be done without assistance of any other person, and that the biopsygun may also be attached to the guide in order to permit the surgeon toe.g. label the container with the tissue or cell specimen whileperforming the biopsy. The method may also include monitoring all theactions in the prostate thru a display device, which will transmitimages captured by the probe.

In another embodiment, methods may include moving the needle in x, y,and z planes. By being able to move the need in x, y, and z planes, thesurgeon is capable of extracting tissue or cell specimens from severaldifferent areas of the prostate without having to retrieve the needleand preventing other perforation of the patient's skin.

Methods may further include removing the access needle from theperennial area. Removal of the access needle may be performed while thebiopsy gun is secured to the access needle or after the biopsy gun hasbeen detached from the access needle.

Methods may include realigning the needle in the desired prostateregion. If the surgeon wishes to start at the right lateral prostateregion and notices that the needle tip is not directed at the lateralregion, the surgeon rolls the ultrasound probe slightly and to note thatthe needle tip is directed to the desired region, then the surgeon mayrealign the needle to obtain tissue or cell specimen. The surgeon mayrealign the needle using one hand while having the needle attached tothe biopsy gun, which may be attached to the probe through the guide.

Methods may include identifying the area in which a biopsy has alreadybeen performed. After each extraction of tissue or cell specimen duringthe biopsy, a hyperechoic streak remains visible on ultrasound display.This allows the surgeon to identify the area of the prostate and that anextraction has been made, as to allow the surgeon to prevent overlap ofextractions.

In another embodiment, methods may include identifying the path of theurethra. This allows the surgeon from preventing passing the biopsyneedle thru or into this path. In another embodiment, the methodincludes pressuring the perineum. In yet another embodiment, the methodincludes applying bacitracin to the skin at the puncture site or anyother type of topical preparation for preventing the possibility ofinfection. In another embodiment, positioning the access needle isperformed without the need of a biopsy grip, wherein the guide providesthe precise point for the biopsy.

An apparatus and system in accordance with embodiments discussed aboveis used to carry out these methods. In an alternative embodiment ofapparatus and systems, a guide may not include a lower mount, and mayinclude an access needle. The guide includes a stabilization bar,sliding platform, a hole located in approximately the center of theplatform, an upper mount, teeth, aperture, arms, and a connector. Theaccess needle includes a hub and is secured to the guide. The teeth maybe part of, or may be attached to, a lower mount. The teeth may beinserted into the aperture in order to secure the guide to a probe, forexample. It is contemplated that the combination of the aperture and theteeth may form a fastener mechanism. In embodiments, connector is partof, or may be attached to, an access needle, and may be secured to theupper mount in order to provide stabilization of the access needle andto allow the practitioner to move the access needle by merely moving,for example, a probe that may be secured to the guide.

A connector and a hub permit the use of various other instruments suchas, for example, a non-biopsy instrument, to be secured. A biopsyinstrument may be inserted into the access needle in order to reach atargeted area. The upper mount may include arms. In embodiments, thearms may be shorter, longer, or may not exists, in which case theaperture is disposed directly in the upper mount. When the aperture isdirectly in the upper mount, upper mount may be longer, thicker, or acombination thereof.

In some embodiments, the guide may include lower mounts that have teeth.Arms may extend from the upper mount to allow the height of the guide tobe adjusted and to be placed farther from or closer to the probe. Thearms permit the access needle to be maintained at a certain distancefrom a probe. In embodiments, the material of the guide may be a plasticor any other material, including other plastic materials, or any othermaterial that is cost effective. In embodiments, the guide may bereusable and may be formed with a stainless steel. The lower mount maybe curvilinear and flexible to allow the lower mount to bend ifnecessary to secure the guide to the probe.

While the invention has been described in connection with a number ofembodiments and implementations, the invention is not so limited butcovers various obvious modifications and equivalent arrangements, whichfall within the purview of the appended claims. Although features of theinvention are expressed in certain combinations among the claims, it iscontemplated that these features can be arranged in any combination andorder.

What is claimed:
 1. A method of performing a transperineal prostatebiopsy procedure on a prostate of a patient using an ultrasound probe,the method comprising: positioning a pair of stabilization members of abiopsy guide proximate of a perineal access site leading to theprostate, the pair of stabilization members spaced apart from each otherand supporting a platform configured to slide along a portion of alength of the pair of stabilization members, the platform configured tosupport an access needle, the biopsy guide secured to the ultrasoundprobe such that the platform and the access needle are configured tomove relative to the pair of stabilization members and the ultrasoundprobe; supporting the access needle to the platform; and sliding theplatform and access needle relative to the pair of stabilization membersand the ultrasound probe so the access needle extends into the perinealaccess site.
 2. The method of claim 1, further comprising inserting abiopsy needle through the access needle and into a first location withinthe prostate.
 3. The method of claim 2, further comprising inserting thebiopsy needle through the access needle and into a second locationwithin the prostate, the second location being different than the firstlocation.
 4. The method of claim 3, wherein the access needle remainspositioned within the perineal access site during the insertion of thebiopsy needle into both of the first and second locations.
 5. The methodof claim 1, wherein positioning the pair of stabilization members of abiopsy guide proximate of the perineal access site comprises contactinga distal end of the pair of stabilization members with a perineal skinof the patient.
 6. The method of claim 1, wherein sliding the platformand access needle relative to the pair of stabilization members and theultrasound probe so the access needle extends into the perineal accesssite is performed under ultrasound guidance via the ultrasound probe. 7.The method of claim 1, wherein the platform comprises a hole extendingthere though, and wherein supporting the access needle to the platformcomprises extending a shaft of the access needle through the hole of theplatform.
 8. The method of claim 7, wherein the hole is centrallypositioned on the platform.
 9. The method of claim 1, wherein a groovedarrangement between the platform and the pair of stabilization memberspermits the platform to slide relative to the pair of stabilizationmembers.
 10. The method of claim 9, wherein the pair of stabilizationmembers includes grooves, and the platform includes outer portionsconfigured to slide within the grooves.
 11. The method of claim 1,wherein the platform and the pair of stabilization members are part ofan upper mount of the biopsy guide, the biopsy guide further comprisinga lower mount configured to couple to the upper mount, and configured toengage the ultrasound probe so as to secure the upper mount relative tothe ultrasound probe.
 12. The method of claim 1, wherein the length ofthe pair of stabilization members is generally parallel to alongitudinal axis of the ultrasound probe when the biopsy guide issecured to the ultrasound probe.
 13. A method of performing atransperineal prostate biopsy procedure on a prostate of a patient usingan ultrasound probe, the method comprising: inserting an access needleinto a perineal access site leading to the prostate, the access needleengaged with a platform that is configured to slide on a pair ofstabilization members of a biopsy guide, the access needle beingcentrally positioned between the pair of stabilization members when theaccess needle is engaged with the platform; and inserting a biopsyneedle through the access needle and into a first location within theprostate.
 14. The method of claim 13, further comprising inserting thebiopsy needle through the access needle and into a second locationwithin the prostate, the second location being different than the firstlocation.
 15. The method of claim 14, wherein the access needle remainspositioned within the perineal access site of the prostate during theinsertion of the biopsy needle into both of the first and secondlocations within the prostate.
 16. The method of claim 13, furthercomprising contacting a distal end of the pair of stabilization membersagainst a perineal skin of the patient prior to inserting the accessneedle into the perineal access site.
 17. The method of claim 16,further comprising positioning the perineal skin with the distal end ofthe pair of stabilization members so as to orient the access needle forinsertion of the biopsy needle.
 18. The method of claim 13, whereininserting the access needle into the perineal access site comprisessliding the access needle and platform along a portion of a length ofthe pair of stabilization members.
 19. The method of claim 18, furthercomprising securing the platform at a distal position along the lengthof the pair of stabilization members.
 20. The method of claim 13,further comprising obtaining at least one of a cell and tissue samplefrom the prostate with the biopsy needle.
 21. The method of claim 1,further comprising: inserting a needle through the access needle andinto tissue of the patient; and injecting a substance into the tissue.22. The method of claim 21, wherein the tissue is outside the prostate.23. The method of claim 21, wherein the substance comprises ananesthetic.
 24. The method of claim 13, further comprising: inserting aneedle through the access needle and into tissue of the patient; andinjecting a substance into the tissue.
 25. The method of claim 24,wherein the tissue is outside the prostate.
 26. The method of claim 24,wherein the substance comprises an anesthetic.
 27. A method ofperforming a transperineal prostate biopsy procedure on a prostate of apatient using an ultrasound probe, the patient comprising perineal skinleading to the prostate, the method comprising: engaging a pair ofstabilization members of a biopsy guide with the perineal skin at aperineal access site of the patient; inserting an access needle into theperineal skin at the perineal access site in a first trajectory, theaccess needle positioned between the pair of stabilization members; andtaking a first biopsy by inserting a first biopsy needle through theaccess needle and into a first location within the prostate.
 28. Themethod of claim 27, wherein the access needle is engaged with a platformthat is configured to slide on the pair of stabilization members of thebiopsy guide.
 29. The method of claim 27, further comprising inserting aneedle through the access needle and into tissue of the patient; andinjecting a substance into the tissue.
 30. The method of claim 29,wherein the tissue is outside the prostate.
 31. The method of claim 29,wherein the substance comprises an anesthetic.
 32. The method of claim27, further comprising moving the pair of stabilization members of thebiopsy guide relative to the prostate and with the access needle stillinserted into the perineal skin such that the access needle is orientedin a second trajectory that is different than the first trajectory. 33.The method of claim 32, further comprising taking a second biopsy byinserting a second biopsy needle through the access needle and into asecond location within the prostate, the second location being differentthan the first location.
 34. The method of claim 32, wherein the biopsyguide is coupled to the ultrasound probe, and wherein moving the pair ofstabilization members of the biopsy guide is facilitated by moving theultrasound probe.
 35. The method of claim 27, wherein the biopsy guideis coupled to the ultrasound probe.
 36. A method of performing atransperineal prostate biopsy procedure on a prostate of a patient usingan ultrasound probe configured to provide imaging in at least a sagittalplane, the method comprising: inserting an access needle into a perinealaccess site leading to the prostate, the access needle engaged with aplatform that is configured to slide on a pair of stabilization membersof a biopsy guide that is secured to the ultrasound probe, the accessneedle positioned within the sagittal plane when the access needle isengaged with the platform and when the ultrasound probe provides imagingin the sagittal plane; and inserting a biopsy needle through the accessneedle and into a first location within the prostate.
 37. The method ofclaim 36, further comprising inserting the biopsy needle through theaccess needle and into a second location within the prostate, the secondlocation being different than the first location.
 38. The method ofclaim 37, wherein the access needle remains positioned within theperineal access site of the prostate during the insertion of the biopsyneedle into both of the first and second locations within the prostate.39. The method of claim 36, further comprising contacting a distal endof the pair of stabilization members against a perineal skin of thepatient prior to inserting the access needle into the perineal accesssite.
 40. The method of claim 36, further comprising obtaining at leastone of a cell and tissue sample from the prostate with the biopsyneedle.
 41. The method of claim 36, further comprising: inserting aneedle through the access needle and into tissue of the patient; andinjecting a substance into the tissue.
 42. The method of claim 41,wherein the tissue is outside the prostate.
 43. The method of claim 41,wherein the substance comprises an anesthetic.